ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL- acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled 
ONE2ZEE LIMITED LIABILITY COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DayTime Severe Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Guaifenesin 200mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg)

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

      ο   nasal congestion
      ο   sinus congestion & pressure
      ο   cough due to minor throat & bronchial irritation
      ο   minor aches & pains
      ο   headache
      ο   fever
      ο   sore throat

Warnings:

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 4 softgels in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults & children 12 years of age and over2 softgels with water every 4 hours
Children under 12 years of age ask a doctor

When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Inactive ingredients

polyethylene glycol 400, propylene glycol, povidone k30, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

Other Information:

PRINCIPAL DISPLAY PANEL - Shipping Label

Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules

Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg)

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-015-
EXP DATE:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

Shipper Label

ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL 
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K30 (UNII: U725QWY32X)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapecapsuleSize20mm
FlavorImprint Code IS4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55629-015-0148 in 1 CARTON03/01/2021
1NDC:55629-015-02300 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2021
Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
Establishment
NameAddressID/FEIBusiness Operations
Medgel Private Limited677385498manufacture(55629-015) , analysis(55629-015)

Revised: 2/2021
Document Id: 08fa64e1-619b-452e-9e2e-a6569daae95a
Set id: de4d25ea-6f0e-49d8-b2ad-fdccf95f54ca
Version: 1
Effective Time: 20210228
 
ONE2ZEE LIMITED LIABILITY COMPANY